Impact of 0.1% and 0.2% Sodium Hyaluronate on Postoperative Discomfort Following Phacoemulsification Surgery

Not Applicable

Completed

• Conditions: Cataract
• Interventions: Drug: Sodium Hyaluronate 0.2% drops; Drug: Sodium Hyaluronate 0.1% drops

• Registration Number: NCT03705949
• Lead Sponsor: Democritus University of Thrace

Brief Summary

Primary objective of the study is the assessment of the patients' discomfort following cataract extraction surgery by means of phacoemulsification and intraocular lens implantation.

Detailed Description

Participants will be recruited from the Cataract Service of the University Hospital of Alexandroupolis (UHA), the Naval Hospital in Athens, the Papanikolaou General Hospital in Thessaloniki, and Athinaiki General Clinic in Athens in a consecutive-if-eligible basis. By means of a custom computer randomization program all participants will randomly populate either study group \[who will receive fixed combination of tobramycin and dexamethasone (FCTD), (Tobradex, Alcon, Greece) quid for 3 weeks and 0.2 % sodium hyaluronate (Hylogel, Pharmex, Greece) quid for 6 weeks\], and control group \[who will receive Tobradex quid for 3 weeks and 0.1 % sodium hyaluronate (Hylocomod) quid for 6 weeks\].

Study Timeline

• Study Start: 2017-09-15
• Primary Completion: 2018-09-15
• Study Completion: 2018-09-15
• Status Verified: 2018-10
• Study First Submitted: 2018-10-11
• Study First Submitted QC: 2018-10-11
• Last Update Submitted: 2018-10-11
• Study First Posted: 2018-10-15
• Last Update Posted: 2018-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• Diagnosis of senile cataract with stage 2 or 3 nuclear opalescence according to the - Lens Opacities Classification System III (LOCS-3) grading scale

Exclusion Criteria

1. Diagnosis or evidence of dry-eye-disease (DED)
2. IOP-lowering medications
3. Former incisional surgery
4. Former diagnosis of corneal disease
5. Diabetes
6. Autoimmune diseases
7. Mental diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study group	Sodium Hyaluronate 0.2% drops	Sodium Hyaluronate 0.1% drops
Control group	Sodium Hyaluronate 0.1% drops	Sodium Hyaluronate 0.2% drops

Primary Outcome Measures

Name	Time	Method
Surface Discomfort Index	6 weeks	A subjective parameter that quantifies corneal discomfort

Secondary Outcome Measures

Name	Time	Method
Break up time	6 weeks	An objective parameter that quantifies stability of tear film
Central Corneal Sensitivity	6 weeks	An objective parameter that quantifies corneal sensitivity

Trial Locations

Locations (1)

University Hospital of Alexandroupolis; 🇬🇷 Alexandroupolis, Evros, Greece